FDA.reportPublic FDA data

Activated Mineral Sunscreen Tinted

Product NDC
83083-002
11-digit product format
830830002
Labeler code
83083
Product ID
83083-002_452053bf-8b70-6550-e063-6294a90a23be
Type
HUMAN OTC DRUG
Nonproprietary name
Activated Mineral Sunscreen Tinted
Dosage form
CREAM
Route
TOPICAL
Labeler
Reve Skincare LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-25
Substance
ZINC OXIDE
Active strength
142.8 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Activated Mineral Sunscreen Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE142.8 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312a32a7-d253-f10c-e063-6294a90a803aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83083-002-50Activated Mineral Sunscreen Tinted1 in 1 CARTONCREAM12
83083-002-50Activated Mineral Sunscreen Tinted50 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83083-002ACTIVATED MINERAL SUNSCREEN TINTED CREAM [REVE SKINCARE LLC]1Current NDC, 2 package rows20250327_312a32a7-d253-f10c-e063-6294a90a803a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 199 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 22N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lad8afa83-2844-422c-b2bf-b5a61be368b12025-08-11WarningsExact identifier
application number: M020
ScarAid SPFSILICONE STICK WITH SPFBiodermis, LLC3c19063a-cdde-1bbe-e063-6294a90aa8a22025-08-11WarningsExact identifier
application number: M020
Pro-Sil SPFSILICONE STICK WITH SPFBiodermis, LLC3be06f82-935d-b1c2-e063-6294a90a953c2025-08-11WarningsExact identifier
application number: M020
Curology Daily MoisturizingAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECurology, Inc3c1967fc-bb89-2f7e-e063-6394a90a25122025-08-11WarningsExact identifier
application number: M020
ScarAid US SPFSILICONE STICK WITH SPFBiodermis, LLC3c196fa4-1bd3-7a43-e063-6294a90a4fb72025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 23W MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L96973dee-681b-4c5d-b31f-de05cd79fa182025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 24N MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lecda3658-eca1-48c2-9eff-e22fd1ff70df2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc6f27df4-6de4-45e4-90cb-ea8b0d29dbd32025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L968abacd-8b99-4529-a627-2b56cdf99e1b2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.La9068dc0-bc48-498b-adc9-57ff810384af2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37f01f66-c604-4fc3-a263-2089db91283f2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lbca57893-bd2d-44ac-a503-2f11c3b62bf22025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L37188b77-ab0b-4bea-b839-99e589600a2b2025-08-11WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc89e45d6-2322-4913-a557-e1780a86fd632025-08-11WarningsExact identifier
application number: M020
Sun Bum Face 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1ed89c-6d50-6400-e063-6294a90a14332025-08-11WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9ea4d-3073-c126-e063-6394a90a7c6e2025-08-10WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETId1c5b7a5-73f9-4df6-9469-ce42e4f33ae82025-08-08WarningsExact identifier
application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTEAVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI96efeb92-a276-4ac9-b30a-11b4fa3672632025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER PEACH SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIedeb2ee1-cc84-4254-80c1-6410cd77c4222025-08-08WarningsExact identifier
application number: M020
GR LIP BUTTER STRAWBERRY SPF 15AVOBENZONE, OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI7abe936b-a4d5-457c-9cdd-761b201bb0462025-08-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83083-002-50830830002501 TUBE in 1 CARTON (83083-002-50) / 50 mL in 1 TUBE1 tube2025-03-25NoNoCurrent